Vibration has long been used to decrease the pain of dental injections, but vibrating needles have not been found to be effective in other dermal situations. Use of a simple hand-held vibrating massager has decreased injection pain in adults, and with the adjuvant of cold therapy was tested in both children and adults and found to relieve pain (Baxter et al. 2011; Baxter et al. 2009; Inal and Kelleci 2012).
Increasing vein diameter (vasodilation) is extremely important for venipuncture in children, as well as for circulation in adults. Venipuncture success in emergency department is regularly found to be between 55 and 65% (Taddio et al, 2005; Spandorfer et al. 2005) and can be as low as 49% in children (Hess 2010).
Devices in the prior art that have sought to induce vasodilation have used dramatically different means, including electrical stimulation and subsequent muscle contraction (US 2011/0071595), vacuum suction (U.S. Pat. No. 5,454,778), and compression (U.S. Pat. No. 6,129,688). Moreover, none of these devices are intended for increasing the success of venipuncture or reducing pain and discomfort associated with low blood flow.
Therefore, there is a need for an intentional agent (device and/or method) to increase vasodilation contributing to the success of venipuncture, improve blood flow for healing, and decrease claudication (pain from inadequate blood flow), which would include both vibration stimulation and a shape suitable to conform to the body. Such a device should be reusable, easy to clean, tolerable to children and adults, and should incorporate a method to be adapted for use in the developing world (for example, operation with a power cord, with a battery, with a solar or light cell, or without the need for external power). As ease of use is critical in this environment, embodiments that include rechargeable options, moveable locations, optional numbers of vibration units, or the option to include cold or heat also are contemplated.
Accordingly, there is a need for a device method that allows for the local improvement of blood flow, improvement of circulation in blocked ducts, veins or arteries, and for pain control and irritating sensation control. There also is a need for a device and method using vibration or a combination of vibration and thermal element that is applied to a subject prior to and/or during the provision of medications that create a burning or itching sensation when administered to a subject. It is to these needs and others that the present invention is directed.